Phase 3 Study of Isentress for Treatment-Naive Adult HIV-1 Patients

Merck announced results from its Phase 3 study of Isentress (raltegravir) in combination therapy compared to efavirenz in combination therapy for treatment-naive HIV-1 infected adult patients. In this ongoing multicenter, double-blind, randomized, active-controlled, non-inferiority study, 563 previously untreated HIV-1 infected adult patients received either 400mg Isentress orally twice-daily (N=281) or 600mg efavirenz orally once-daily (N=282), each in combination with tenofovir/emtricitabine. The primary endpoint of the study was a reduction in HIV-1 viral load to <50 copies/mL. Secondary endpoints included antiretroviral (ARV) activity, as measured by the percentage of patients achieving HIV-1 viral load to <50 copies/mL, <400 copies/mL, and change from baseline in CD4-cell count at Week 96, as well as tolerability and safety at Week 96.